BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052164 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03700
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PHYSICIAN HAD ORDERED A CHEST X-RAY TO DISCERN THE INTEGRITY OF THE RV LEAD PACE/SENSE CONNECTION. HIGH IMPEDANCES HAVE BEEN SHOWN PERIODICALLY ON THE RV LEAD. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCES. THE ALERT WS DELIVERED AND DISCUSSED WITH THE PATIENT'S CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT ADDITIONAL RED ALERTS WERE DETECTED DUE TO HIGH RV IMPEDANCES. IT WAS NOTED THAT THE MEASUREMENTS WERE INTERMITTENTLY OUT OF RANGE. THE PATIENT WAS BROUGHT IN TO THEIR CLINIC FOR LEAD TESTING, WHICH WAS NOTED TO APPEAR NORMAL, AND NOISE WAS UNABLE TO BE PRODUCED WITH PATIENT ISOMETRICS. ADDITIONAL TROUBLESHOOTING OPTIONS WERE QUESTIONED, AS THE PATIENT WAS TO RETURN TO THE CLINIC FOR ADDITIONAL DISCUSSIONS AND LEAD TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT AN X-RAY WAS PERFORMED, WHICH CONFIRMED A LEAD FRACTURE. THE LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention H175| 4087| 4517| N118| 0157